Brief Summary
This is a phase 1/2, dose-escalation and cohort-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advancedat a late stage, far along solid tumors.
Intervention / Treatment
- Drug: DT-7012
- Drug: Immune checkpoint inhibitor
Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor, among selected cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs types, that is recurrent, locally advanced (i.e., not eligible for curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the local site investigator/radiologist.
- At least 1 tumoura tissue mass that forms from groups of unhealthy cells lesion accessible to biopsyremoval of a section of tissue to analyse for cancer cells per treating physician judgement.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) PS of 0 or 1.
- Adequate organ function.